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FlowFlex Sar-CoV-2 Antigent Rapid Test
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Product Data
Clinical Performance
Specification
Product Data
The Flowflex SARS-CoV-2 Antigen Rapid Test (Self -Testing) is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of an active COVID-19 infection by their
healthcare provider within the first seven days of the onset of symptoms.
- Nasal swab specimens
- Results in 15 minutes
- Excellent performance compared to molecular methods
- Room temperature storage
Clinical Performance
The performance of Flowflex SARS-CoV-2 Antigen Rapid Test
Specification
| Feature | Specification |
| Test Format | Cassette |
| Specimen Format | Anterior nasal swab specimens |
| Detects | The nucleocapsid protein antigen from SARS-CoV-2 |
| Sample Volume | 4 drops of the prepared specimen |
| Relative Sensitivity | 97.1% (95% CI: 93.1%-98.9%) 95% Confidence Intervals |
| Relative Specificity | 99.5% (95% CI: 98.2%-99.9%) 95% Confidence Intervals |
| Accuracy | 98.8% (95% CI: 97.6%-99.5%） 95% Confidence Intervals |
| Test Time | 15 minutes |
| Shelf Life | 24 Months |
| Store Temperature | 2 – 30 °C |
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